Neuroinflammatory and Neurocognitive Effects of Spinal vs. Inhalational Anesthesia for Elective Surgery in Infants
Status:
Withdrawn
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
Significant concern regarding the safety of general anesthesia in children has arisen due to
myriad animal studies suggesting neurotoxicity of commonly used anesthetic agents.
Inflammation of the central nervous system after anesthesia may have a significant role in
the pathogenesis of anesthetic-induced neural injury. To evaluate this hypothesis, the
investigators propose to randomize healthy infants undergoing elective surgery to one of two
anesthetics: 1) spinal anesthesia only; or 2) general inhalational anesthesia with
isoflurane, laryngeal mask airway (LMA) or endotracheal tube (ETT), and single-shot caudal
block. Primary endpoint will be serum inflammatory biomarkers and transcriptome analysis and
secondary endpoint will be neurocognitive outcome at 6 months and 1 year.